ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION
Device Facts
| Record ID | K951319 |
|---|---|
| Device Name | ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | DOE · Clinical Toxicology |
| Decision Date | Jun 1, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3640 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A morphine test system is a device intended to measure morphine, an addictive narcotic pain-relieving drug, and its analogs in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of morphine use or overdose and in monitoring levels of morphine and its analogs to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). A morphine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
